Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants

Pulmonary Atelectasis Clinical Trial

Official title:

Preventive Effect of Lung Ultrasound and Alveolar Recruitment on Atelectasis in Mechanically Ventilated Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584023
• Other study ID #: H-1509-063-703
• Status: Completed
• Phase: N/A
• First received: October 20, 2015
• Last updated: June 21, 2016
• Start date: October 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be beneficial in mechanically ventilated infants compared to those who did not receive lung ultrasound and alveolar recruitment maneuver.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• Minor surgery less than 2 hours under general anesthesia

• Mechanically ventilated after endotracheal intubation

Exclusion Criteria:

• History of surgery on the lungs

• Laparoscopic surgery

• Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia

• Considered inappropriate by the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pulmonary Atelectasis

Intervention

Device:
• Lung ultrasound
Lung ultrasound on both hemithorax in supine position

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Acosta CM, Maidana GA, Jacovitti D, Belaunzarán A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231. — View Citation

Ashton-Cleary DT. Is thoracic ultrasound a viable alternative to conventional imaging in the critical care setting? Br J Anaesth. 2013 Aug;111(2):152-60. doi: 10.1093/bja/aet076. Epub 2013 Apr 12. Review. — View Citation

Kiley S, Cassara C, Fahy BG. Lung ultrasound in the intensive care unit. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):196-203. doi: 10.1053/j.jvca.2014.10.017. Review. — View Citation

Lutterbey G, Wattjes MP, Doerr D, Fischer NJ, Gieseke J Jr, Schild HH. Atelectasis in children undergoing either propofol infusion or positive pressure ventilation anesthesia for magnetic resonance imaging. Paediatr Anaesth. 2007 Feb;17(2):121-5. — View Citation

Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. Review. — View Citation

Tusman G, Böhm SH, Tempra A, Melkun F, García E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative incidence of pulmonary atelectasis		within the first day after the surgery	Yes
Secondary	Intraoperative incidence of pulmonary atelectasis after endotracheal intubation		from the moment of endotracheal intubation until the end of surgery, up to 6 hours	Yes
Secondary	Intraoperative incidence of pulse oximetry (SpO2) = 95% (or 10% below the baseline value)		from the induction of general anesthesia until the end of the surgery, up to 6 hours	Yes
Secondary	Postoperative incidence of pulse oximetry (SpO2) = 95% (or 10% below the baseline value)		within the first day after the surgery	Yes